Cranial remodeling is utilized to correct for deformities in the head shapes of infants. Prior to the development of the Dynamic Orthotic CranioplastySM method of cranial remodeling by Cranial Technologies, Inc, the assignee of the present invention, the only viable approach for correction of cranial deformities was surgical correction of the shape of the cranium. Dynamic Orthotic CranioplastySM utilizes a treatment protocol in which the DOC BAND® cranial remodeling device is custom produced for each subject to be treated.
In the past, custom cranial remodeling devices were produced by first obtaining a full size and accurate cast of the actual head shape of each subject. This cast was then modified to produce a second or desired head shape model. The second or desired head shape model is used to form the cranial remodeling band for the infant. In the past, the second or desired shaped head shape model was obtained by manually modifying the first cast to form the desired shape model.
Cranial Technologies has maintained a “library” of the casts of the head casts of infant's deformed heads and the corresponding models of the desired corrected head shapes.
Cranial Technologies, Inc. continued its pioneering developments with its proprietary DSI® digital image capturing system and its Digital Surface Imaging®methodology for the time efficient and safe image capture of three-dimensional full head images.
More specifically, the DSI® digital image capturing system was utilized to capture DR® digital data representative of digital images of each cast of a deformed head and each corresponding model of the corrected head shape and store the DSI® digital data for each digital image in first and second databases, respectively. The first and second databases were utilized to train a neural network.
In its continuing efforts, Cranial Technologies further developed a system that utilized these first and second databases to automatically produce digital data representative of a modified head shape from DSI® digital data representative of a deformed head.
The data representative of the deformed head is utilized to provide a full size replica of the modified head shape. On that full size replica, a polymer plastic material is formed as a step in the production of a custom DOC BAND® cranial remodeling device.
After the polymer plastic material is formed on the full size replica, the polymer plastic material must be cut as step in forming a final DOC BAND® cranial remodeling device. The cutting of the material is along trim lines that are customized for the specific customized DOC BAND® cranial remodeling device.
Cranial Technologies further developed a methodology and a computer program implementing that methodology to generate corresponding trim lines for each customized DOC BAND® cranial remodeling device. That methodology is the subject of prior patents owned by Cranial Technologies, Inc.
With the methodology and computer program it is possible for to use a Computer Numerical Control (CNC) machine cutting tool to directly cut the shape of the cranial remodeling device in the polymer plastic material utilizing the computer generated trim line.
Although it is possible to automatically cut along the computer system generated trim lines, we have determined that it is desirable to first draw or mark the trim lines on the polymer plastic surface. Drawing the trim lines allows a product finisher to use skilled judgment to adjust the trim lines as necessary in finishing the product.
We discovered that there is considerable difficulty in drawing or marking the trim lines on the complex three-dimensional surface of a cranial remodeling device. Although CNC machines are particularly useful when cutting a complex three-dimensional bodies, it is difficult to program a tool to just contact the surface of a complex three-dimensional surface with perfect accuracy to provide trim line markings on the surface. The problem is especially aggravated where the surface being marked is a plastic surface. When the plastic surface is digitized, the inherent noise that occurs in the digitization appears as surface variations to the CNC machine
We tried to find a marking tool usable in a CNC machine that could be used to draw trim lines as part of our manufacturing process. We found commercially available rigid drawing or marking tools that are suitable for use in CNC machines. However, all of those marking tools require 100% accuracy in locating the surface. If the location of the surface is not perfectly located, the marking tool may impact the surface and break or damage the surface, or the marking tool may not actually touch the surface with the result that the trim line is not drawn, or the marking tool may when drawing the trim line damage the surface in portions, mark the surface in portions, and miss the surface in other portions.
Many commercially available marking tools were investigated for suitability in marking trim lines onto polymer plastic three-dimensional complex surfaces. None of the commercially available marking tools was effective. For these and other reasons, we determined that it was desirable to provide apparatus that would consistently and effectively drawing lines onto the complex surface of a three-dimensional object without risk of damage to the surface and without requiring perfect placement onto the surface.